Suturing instrument

ABSTRACT

Suturing instruments in accordance with the invention are dimensioned and configured to apply sutures to approximate, ligate, or fixate tissue in, for example, open, mini-incision, transvaginal, laparoscopic, or endoscopic surgical procedures. In some embodiments, the suturing instruments include a distal portion that is deflectably and/or pivotally coupled to the remainder of the instrument for improved maneuverability and functionality during surgery. In other embodiments, the suturing instruments are capable of housing multiple needle and suture assemblies and/or reloading the needle and suture assembly without removing the instrument from the surgical site.

REFERENCE TO RELATED APPLICATIONS

This is a continuation of and claims the benefit of and priority to U.S.patent application Ser. No. 12/233,145, filed on Sep. 18, 2008, which isa continuation of U.S. patent application Ser. No. 10/459,784, filed onJun. 12, 2003, now U.S. Pat. No. 7,442,198, which claims priority to andbenefit of U.S. Provisional Application Ser. No. 60/388,458, filed onJun. 12, 2002. The entirety of each of these related cases isincorporated herein by reference.

TECHNICAL FIELD

The invention relates to medical devices and, more specifically, todevices for approximation, ligation, or fixation of tissue usingsutures.

BACKGROUND INFORMATION

Suturing of body tissue is a time consuming aspect of many surgicalprocedures. For many surgical procedures, it is necessary to make alarge opening in the human body to expose the area that requiressurgical repair. There are instruments available that allow for viewingof certain areas of the human body through a small puncture woundwithout exposing the entire body cavity. These instruments, calledendoscopes, can be used in conjunction with specialized surgicalinstruments to detect, diagnose, and repair areas of the body thatpreviously required open surgery to access.

Some surgical instruments used in endoscopic procedures are limited bythe manner in which they access the areas of the human body in need ofrepair. In particular, the instruments may not be able to access tissueor organs located deep within the body or that are in some wayobstructed. Also, many of the instruments are limited by the way theygrasp tissue, apply a suture, or recapture the needle and suture.Furthermore, many of the instruments are complicated and expensive touse due to the numerous parts and/or subassemblies required to make themfunction properly.

Suturing instruments, and more specifically suturing instruments used inendoscopic procedures, are generally rigid and do not provide theoperator a range of motion to access difficult to reach parts of theanatomical region requiring sutures. Accordingly, multiple instrumentsof various configurations and sizes must be used to access all of thenecessary tissue areas. These limitations of suturing instrumentscomplicate the endoscopic procedure for the surgeon by requiring theinsertion and removal of multiple instruments from a surgical site asthe target suturing area changes during the course of the surgicalprocedure.

Many medical procedures require that multiple sutures be placed within apatient. Typical suturing instruments enable a surgeon to place only onesuture at a time. With such suturing instruments, the surgeon isrequired to remove the instrument from a surgical site and reload theinstrument between placing each suture. Further, the surgeon may berequired to use forceps or other instruments to help place the suture.In some instances, the forceps or other instruments may require anadditional incision to access the surgical site.

Thus, suturing remains a delicate and time-consuming aspect of mostsurgeries, including those performed endoscopically. Accordingly, thereis an unresolved need in the art to provide a suturing instrument withimproved maneuverability, efficiency, and functionality during asurgical procedure.

SUMMARY OF THE INVENTION

The invention generally relates to surgical instruments for performing asurgical procedure, such as placing one or more sutures through tissue.The suturing instruments disclosed herein are dimensioned and configuredto apply sutures to approximate, ligate, or fixate tissues in, forexample, open, mini-incision, trans-vaginal, laparoscopic, or endoscopicsurgical procedures.

More particularly, in some embodiments, the invention is directed tosuturing instruments that include a distal portion that is deflectablyand/or pivotally coupled to the remainder of the instrument for improvedmaneuverability and functionality during surgery

In other embodiments the invention is directed to suturing instrumentscapable of housing multiple needle and suture assemblies and/orreloading the needle and suture assembly without removing the instrumentfrom the surgical site. Such suturing instruments allow a surgeon toplace multiple sutures without having to reload the instrument aftereach suture is placed, which is more efficient and less invasive than aprocedure where the surgeon has to remove the instrument from thesurgical site to reload. This is particularly helpful when the surgicalsite is located deep within a body and not easily repeatably accessible.

In general, in a first aspect, the invention features a suturinginstrument that includes an elongate body member having a middle portionand a distal portion. The distal portion extends distally from themiddle portion and is deflectable at a predetermined angle relative tothe middle portion. The predetermined angle of deflection of the distalportion may range from about −90° to about 90°. The suturing instrumentalso includes a needle deployment mechanism disposed at least partiallywithin the elongate body member. The needle deployment mechanism isconnectable to a needle for moving the needle out of the distal portionof the elongate body member.

In one embodiment according to the first aspect of the invention, theelongate member also includes at least one tension member that isslidably disposed at least partially in the elongate member and isconnected to its distal portion. In this embodiment, the suturinginstrument may include at least one deflection control member coupled tothe tension member and disposed opposite the distal portion of theelongate body member for controlling deflection of the distal portion.

In another embodiment according to the first aspect of the invention,the distal portion is pivotable about a first axis that is perpendicularto the longitudinal axis of the elongate body member. In thisembodiment, the suturing instrument may include a first pivot controllever disposed opposite the distal portion of the elongate body member,and a pivot wire rotatably disposed in the elongate body member andcoupled to the distal portion. The first pivot control lever may becoupled to the pivot wire for controlling pivoting of the distalportion.

In yet another embodiment according to the first aspect of theinvention, the distal portion includes a first beveled surface forcontacting the middle portion and the middle portion includes a secondbeveled surface for contacting the distal portion. According to onefeature of this embodiment, a first angle defined by the first beveledsurface and a second angle defined the second beveled surface aresubstantially equal. The sum of the angles may substantially equal 90°.According to another feature, the elongate body member includes a firstresilient member for biasing the distal portion towards the middleportion along a longitudinal axis of the elongate member. The suturinginstrument of this embodiment may also include a deflection controlmechanism coupled to the distal portion for deflecting the distalportion at the predetermined angle relative to the middle portion byrotating the distal portion about a longitudinal axis of the elongatebody member.

In still another embodiment according to the first aspect of theinvention, the elongate body member includes a locking mechanism forsecuring the distal portion at the predetermined angle relative to themiddle portion. The locking mechanism may include a first plurality ofteeth disposed on the first beveled surface and a second plurality ofteeth disposed on the second beveled surface that are configured to meshwith the first plurality of teeth. Alternatively, the locking mechanismmay include a plurality of detents that are defined by the first beveledsurface and are circumferentially disposed about the first beveledsurface; and a ball disposed in the second beveled surface anddimensioned to fit at least one of the plurality of detents. In thisfeature, the second beveled surface may define an aperture for receivingthe ball therein. Also, a second resilient member may be disposed in theaperture for biasing the ball into engagement with the at least one ofthe plurality of detents.

In yet another embodiment according to the first aspect of theinvention, the needle deployment mechanism includes a needle carrierthat is disposed at least partially within the distal portion of theelongate body member and is slidably movable out of the distal portion.The needle deployment mechanism optionally includes an actuator coupledto the needle carrier and disposed opposite the distal portion. Theactuator may be at least partially housed by a handle disposed oppositethe distal portion.

The invention is also related generally to a method for placing suturesin tissue. The method includes the step of providing a suturinginstrument having an elongate body member that includes a middle portionand a distal portion extending distally from the middle portion anddeflectable at a predetermined angle relative to the middle portion; anda needle deployment mechanism disposed at least partially within theelongate body member and connectable to a needle for moving the needleout of the distal portion. The method further includes the steps ofdisposing a needle within the distal portion; disposing the suturinginstrument in a body; deflecting the distal portion of the suturinginstrument thereby positioning the distal portion proximal to thetissue; and actuating the needle deployment mechanism thereby moving theneedle out of the distal portion and through the tissue.

In general, in a second aspect, the invention features a suturinginstrument that includes an elongate body member having a longitudinalaxis. The elongate body member has a distal portion that is pivotableabout at least one axis that is substantially perpendicular to thelongitudinal axis of the elongate body member. The suturing instrumentalso includes a needle deployment mechanism disposed at least partiallywithin the elongate body member. The needle deployment mechanism isconnectable to a needle for moving the needle out of the distal portion.Also, the elongate body member may include a handle disposed oppositethe distal portion.

In one embodiment according to the second aspect of the invention, thesuturing instrument also includes a pivot control lever disposedopposite the distal portion of the elongate body member for controllingpivoting of the distal portion. In a first version of this embodiment,the suturing instrument includes a pivot mechanism disposed in theelongate body member and coupled to the distal portion. The pivotcontrol lever may be coupled to the pivot mechanism for controllingpivoting of the distal portion. In a second version of this embodiment,the elongate body member may include an inner portion coupled to thedistal portion, and an outer portion coupled to the pivot control leverand slidably disposed at least partially along the inner portion.According to one feature, the suturing instrument also has a linkagecoupled to the outer portion and the distal portion. The linkage isconfigured to cause the distal portion to pivot about the first axiswhen the outer portion is displaced relative to the inner portion.According to another feature, the suturing instrument also includes aresilient member for biasing the outer portion towards the proximalportion of the elongate body member.

Further, in various features of the needle deployment mechanism of thisembodiment of the suturing instrument, the needle deployment mechanismincludes a needle carrier that is disposed at least partially within thedistal portion of the elongate body member and is slidably movable outof the distal portion.

According to one particular feature of the second version of thisembodiment, the needle deployment mechanism also has a resilient loop ofmaterial disposed at least partially within the elongate body member andcoupled to the needle carrier. The needle deployment mechanism alsoincludes an actuator that is coupled to the needle carrier via theresilient loop of material to move the needle carrier of the distalportion. The actuator may be at least partially housed by the handle.

According to another feature, the needle deployment mechanism alsoincludes a needle carrier control rod that is slidably disposed at leastpartially within the elongate body member and coupled to the needlecarrier. The needle carrier control rod may optionally be made of asuperelastic material, such as a nickel-titanium alloy. The needlecarrier control rod is configured to move the needle carrier when theneedle carrier control rod is slidably advanced. The needle deploymentmechanism may include an actuator coupled to the needle carrier controlrod to advance the needle carrier control rod. The actuator is disposedopposite the distal portion of the elongate member, for example, atleast partially housed by the handle.

According to yet another feature of the second version of thisembodiment, the needle deployment mechanism also includes a camshaftdisposed within the distal portion of the elongate body member andcoupled to the needle carrier and a drum rotatably disposed within thedistal portion of the elongate body member and coupled to the camshaftfor moving the camshaft when the drum rotates. The needle deploymentmechanism according to this feature further includes a push wireslidably disposed within the elongate body member and having a distalend coupled to the drum for causing the drum to rotate. The needledeployment mechanism may also include an actuator coupled to a proximalend of the push wire for advancing the push wire. The actuator isdisposed opposite the distal portion of the elongate member, forexample, at least partially housed by the handle.

In another embodiment according to the second aspect of the invention,the distal portion of the suturing instrument includes a first gear thatis rotatable about a first axis substantially perpendicular to thelongitudinal axis of the elongate body member. According to one featureof this embodiment, a middle portion of the elongate body memberincludes a second gear rotatable about the longitudinal axis and meshedwith the first gear. According to this feature, the distal portionpivots about the first axis when the second gear rotates about thelongitudinal axis. Optionally, the suturing instrument includes a pivotcontrol mechanism disposed at least partially within the middle portionand coupled to the second gear for causing the second gear to rotateabout the longitudinal axis, a pivot control lever disposed opposite thedistal portion of the elongate body member and coupled to the pivotcontrol mechanism for controlling pivoting of the distal portion.

In yet another embodiment according to the second aspect of theinvention, the distal portion is rotatable about the longitudinal axisof the elongate body member. In this embodiment, the suturing instrumentmay include a rotation control mechanism disposed opposite the distalportion of the elongate body member, and a rotation rod rotatablydisposed in the elongate body member and coupled to the distal portion.The rotation control mechanism may be coupled to the rotation rod forcontrolling rotation of the distal portion.

In general, in a third aspect, the invention features a suturinginstrument for use with an endoscope. The suturing instrument accordingto this aspect of the invention includes an elongate body member havinga flexible tubular member and a distal portion attached to a distal endof the flexible tubular member. The flexible tubular member isdimensioned to slidably and rotationally fit within a working channel ofan endoscope. The suturing instrument according to this aspect of theinvention also includes a needle deployment mechanism disposed at leastpartially within the elongate body member and connectable to a needlefor moving the needle out of the distal portion.

In one embodiment according to the third aspect of the invention, theneedle deployment mechanism includes a needle carrier that is disposedat least partially within the distal portion of the elongate body memberand is slidably movable out of the distal portion; a carrier drive wireslidably disposed within a lumen defined by the flexible tubular memberand coupled to the needle carrier; and an actuator coupled to thecarrier drive wire. According to one feature of this embodiment, theelongate body member may include a proximal portion including a handleat least partially housing the actuator. The tubular member may bereleasably attached to the proximal portion. Optionally, the distalportion is rotatable about a longitudinal axis of the elongate bodymember relative to the proximal portion. The suturing instrument mayalso include a rotation control mechanism disposed in the proximalportion of the elongate body member for controlling rotation of thedistal portion. Also, according to this feature, the proximal portionincludes a carrier drive wire socket releasably coupled to the proximalportion for receiving the carrier drive wire. The proximal portion mayalso include a locking socket that is rotationally and releasablycoupled to the carrier drive wire socket and serves to secure a proximalend of the tubular member. Further, the proximal portion may alsoinclude a scope adapter for securing the proximal portion to the workingchannel of the endo scope.

In another embodiment according to the third aspect of the invention,the distal portion of the elongate body member is pivotable about afirst axis, which is substantially perpendicular to a longitudinal axisof the elongate body member.

Also, the invention features a method for placing sutures in tissue. Themethod includes the step of providing an endoscope defining a workingchannel through. The working channel of the endoscope has an opening ata distal end of the endoscope. The method further includes the step ofproviding a suturing instrument that includes an elongate body memberhaving a flexible tubular member with a distal end and a proximal end;the flexible tubular member dimensioned to slidably and rotationally fitwithin the working channel of the endoscope, and a distal portionattached to the distal end of the flexible tubular member. The suturinginstrument also includes a needle deployment mechanism disposed at leastpartially within the elongate body member and connectable to a needlefor moving the needle out of the distal portion. The method alsoincludes the steps of inserting the proximal end of the flexible tubularmember into the opening; passing the flexible tubular member through theworking channel of the endoscope, disposing a needle within the distalportion, disposing the endoscope within a body, positioning the distalportion proximal to the tissue, and actuating the needle deploymentmechanism thereby moving the needle out of the distal portion andthrough the tissue.

In various embodiments according to the foregoing aspects of theinvention, the suturing instrument includes a needle disposed within thedistal portion. Also, the distal portion of the suturing instrument ofclaim may include a needle catch configured to receive a needle, theneedle catch defining a retention slot including at least two flexibleedges.

In general, in a fourth aspect, the invention features a suturinginstrument that includes an elongate body member having a distalportion. The distal portion includes a needle catch defining anaperture. The suturing instrument according to this aspect of theinvention includes a needle deployment mechanism disposed at leastpartially within the elongate body member for moving a needle out of thedistal portion and to the needle catch as well as a needle reloadingmechanism disposed at least partially within the elongate body memberfor pushing the needle into the aperture of the needle catch. The needlecatch is optionally slidably movable along a longitudinal axis of theelongate body member.

In one embodiment according to the fourth aspect of the invention, theneedle deployment mechanism includes a needle carrier that is disposedat least partially within the distal portion of the elongate body memberand is slidably movable out of the distal portion. The needle deploymentmechanism also includes an actuator that is coupled to the needlecarrier and disposed opposite the distal portion of the elongate bodymember. The needle carrier has a distal end that, optionally, defines alumen for receiving the needle therein.

In another embodiment according to the fourth aspect of the invention,the needle reloading mechanism includes a pusher rod and a rod actuatorfor moving the pusher rod towards the distal portion of the elongatebody member. According to one feature of this embodiment, the rodactuator is disposed opposite the distal portion of the elongate bodymember substantially perpendicularly to the pusher rod. According toanother feature, the pusher rod comprises a substantially concave distalend. Also, according to yet another feature, the needle reloadingmechanism has a hook coupled to a resilient member for biasing thepusher rod away from the distal portion of the elongate body member.

In still another embodiment according to the fourth aspect of theinvention, the needle catch defines a retention slot including at leasttwo flexible edges for retaining the needle therein, the retention slotin communication with the aperture. At least one of the flexible edgesmay have at least one protrusion extending into the retention slot.According to another feature of this embodiment, the suturing instrumentincludes a needle disposed within the distal portion. The needle has asuture attached thereto and is releasable from the needle catch bypulling on the free end of the suture after the needle reloadingmechanism pushes the needle into the aperture.

In yet another embodiment according to the fourth aspect of theinvention, the suturing instrument also includes a handle disposedopposite the distal portion of the elongate body member, which at leastpartially houses the needle deployment mechanism and the needlereloading mechanism.

In general, in a fifth aspect, the invention features a suturinginstrument that includes an elongate body member having a distalportion. The distal portion includes a first operative portion and asecond operative portion. The suturing instrument also includes a needledeployment mechanism that is disposed at least partially within theelongate body member and includes a first needle carrier disposed atleast partially within the first operative portion and connectable to afirst needle for moving the first needle out of the first operativeportion, and a second needle carrier disposed at least partially withinthe second operative portion and connectable to a second needle formoving the second needle out of the second operative portion.

In a first embodiment according to the fifth aspect of the invention,the suturing instrument includes a handle that is disposed opposite thedistal portion of the elongate body member and at least partially housesthe needle deployment mechanism.

In a second embodiment according to the fifth aspect of the invention,the first operative portion and the second operative portion of thedistal portion form a unitary operative portion.

In a third embodiment according to the fifth aspect of the invention,the suturing instrument includes an actuator coupled to the first needlecarrier and the second needle carrier and disposed opposite the distalportion of the elongate body member. According to one feature of thisembodiment, the actuator includes a first sub-actuator coupled to thefirst needle carrier and a second sub-actuator coupled to the secondneedle carrier. The first needle carrier and the second needle carrierare actuatable either sequentially or simultaneously.

In a fourth embodiment according to the fifth aspect of the invention,the suturing instrument includes a first needle disposed within thefirst operative portion, and a second needle disposed within the secondoperative portion. According to one feature of this embodiment of thesuturing instrument, a first suture is attached to the first needle anda second suture is attached to the second needle. According to anotherfeature of this embodiment, the suturing instrument includes a suturehaving a first end attached to the first needle and a second endattached to the second needle.

In a fifth embodiment according to the fifth aspect of the invention,the distal portion of the suturing instrument includes a first needlecatch configured to receive a first needle; and a second needle catchconfigured to receive a second needle. Optionally, the first needlecatch and the second needle catch form a unitary needle catch. At leastone of the first needle catch and the second needle catch may define aretention slot including at least two flexible edges.

In a sixth embodiment according to the fifth aspect of the invention,the first operative portion of the distal portion defines a first needleport and the second operative portion of the distal portion defines asecond needle port. In this embodiment, the distance between the firstneedle exit port and second needle exit port is laterally adjustable bydeflecting at least one of the first operative portion and the secondoperative portion outwardly from the elongate body member. According toone feature of this embodiment, the suturing instrument includes adeflecting mechanism for adjusting the distance between the first needleexit port and the second needle exit port. A deflection actuatordisposed opposite the distal portion of the elongate body member may beincluded for actuating the deflecting mechanism. The deflectingmechanism may include, for example, a wedge, a cam, an elbow linkage, arotational separator, and a track-and-follower assembly.

Lastly, in general, in a sixth aspect, the invention features a suturinginstrument that includes an elongate body member having a distalportion. The distal portion includes a needle catch. The suturinginstrument also includes a cartridge that is disposed at least partiallywithin the distal portion and houses a first needle and a second needle,as well as a needle deployment mechanism that is disposed at leastpartially within the elongate body member and is connectablesequentially to the first needle and the second needle for moving thefirst needle and then the second needle from the cartridge out of thedistal portion to the needle catch. The cartridge may be removable fromthe distal portion of the elongate body member or integrally formedwithin the distal portion. Also, the distal portion of the elongate bodymember is optionally rotatable relative to a remainder of the elongatebody member.

Further, in one embodiment of the sixth aspect of the invention, theneedle deployment mechanism includes a needle carrier that is disposedat least partially within the distal portion of the elongate body memberand is slidably movable out of the distal portion and an actuatorcoupled to the needle carrier and disposed opposite the distal portionof the elongate body member.

In another embodiment of the sixth aspect of the invention, thecartridge defines an exit aperture for receiving at least one of thefirst needle and the second needle. According to one feature of thisembodiment, the cartridge further defines a loading slot connected tothe exit aperture. At least of the first needle and the second needlecan be received in the loading slot. The second needle transitions fromthe needle loading slot to the exit aperture after the first needle isdeployed from the cartridge. In one version of this feature, thesuturing instrument includes a pusher for transitioning the secondneedle from the needle loading slot to the exit aperture after the firstneedle is deployed from the cartridge through the opening. Optionally,the pusher includes a push plate for contacting the second needle and aresilient member for biasing the push plate towards the exit aperture.In another version of this feature, the suturing instrument includes asuture having one end attached to the second needle, so that the secondneedle is transitioned from the loading slot to the exit aperture afterthe first needle is deployed from the cartridge by pulling on the freeend of the suture. The suturing instrument may also include a means forpulling the free end of the suture optionally attached to the elongatebody member and disposed opposite the distal portion thereof, such as,for example, a spool or a lever.

In yet another embodiment of the sixth aspect of the invention, thecartridge also contains a third needle. In this embodiment, the needledeployment mechanism is connectable sequentially to the first needle andthe second needle and the third needle for moving the first needle andthen the second needle and then the third needle from the cartridge outof the distal portion to the needle catch.

In still another embodiment of the sixth aspect of the invention, thesuturing instrument includes a handle that is disposed opposite thedistal portion of the elongate body member and at least partially housesthe needle deployment mechanism.

The invention also features a method for placing sutures in multipletissue sites. The method includes the step of providing a suturinginstrument having an elongate body member with a distal portion. Thedistal portion of the suturing instrument includes a needle catch. Thesuturing instrument also has a cartridge disposed at least partiallywithin the distal portion. The cartridge includes a first needledisposed within the cartridge and a second needle disposed within thecartridge. Also, the suturing instrument includes a needle deploymentmechanism disposed at least partially within the elongate body memberand connectable sequentially to the first needle and the second needle.The method of the invention further contemplates the steps of disposingthe suturing instrument in a body, positioning the distal portionproximal to a first tissue site in the body, actuating the needledeployment mechanism thereby moving the first needle out of thecartridge to the needle catch, positioning the distal portion proximalto a second tissue site in the body without withdrawing the suturinginstrument from the body, moving the second needle in the cartridge, andactuating the needle deployment mechanism thereby moving the secondneedle out of the cartridge to the needle catch.

In various embodiments according to the foregoing aspects of theinvention, the elongate body member is adapted to access remote organsor tissue within a body. Also, the suturing instrument disclosed abovemay include one, two, or more bends.

Advantages and features of the present invention herein disclosed willbecome apparent through reference to the following description, theaccompanying drawings, and the claims. Furthermore, it is to beunderstood that the features of the various embodiments described hereinare not mutually exclusive and can exist in various combinations andpermutations.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention. In the followingdescription, various embodiments of the present invention are describedwith reference to the following drawings, in which:

FIG. 1A is a schematic plan view of one embodiment of a suturinginstrument in accordance with the invention;

FIG. 1B is a schematic cross-sectional view of a proximal portion of thesuturing instrument of FIG. 1A;

FIG. 1C is a schematic cross-sectional view of a distal portion of thesuturing instrument of FIG. 1A;

FIG. 2A is a schematic plan view of a needle coupled to a suture for usein a suturing instrument in accordance with the invention;

FIG. 2B is a schematic perspective view of a needle catch for use withthe suturing instrument of FIG. 1A;

FIG. 3A is a schematic perspective view of a distal portion of asuturing instrument including a multi-load needle cartridge inaccordance with the invention;

FIG. 3B is an enlarged cross-sectional view of the suturing instrumentof FIG. 3A;

FIG. 4A is a schematic perspective view of a distal portion of amulti-needle suturing instrument in accordance with the invention;

FIG. 4B is a schematic perspective view of an alternative multi-needlesuturing instrument having two operative portions in accordance with theinvention;

FIG. 4C is an enlarged schematic perspective view of the operativeportions of the suturing instrument of FIG. 4B in an aligned position;

FIG. 4D is an enlarged schematic perspective view of the operativeportions of the suturing instrument of FIG. 4B in a spread position;

FIG. 4E is a schematic perspective view of a single suture placement intissue;

FIG. 4F is a schematic perspective view of a double suture placement intissue;

FIG. 5A is a schematic cross-sectional perspective view of a distalportion of a suturing instrument including a needle reloading mechanismin accordance with the invention;

FIG. 5B is a schematic perspective view of a pusher rod for use with thesuturing instrument of FIG. 5A;

FIG. 5C is a schematic cross-sectional perspective view of a proximalportion of the suturing instrument of FIG. 5A;

FIGS. 5D-5F are schematic plan views of the needle reloading mechanismof the suturing instrument of FIGS. 5A-5C in operation;

FIG. 5G is a schematic cross-sectional view of a modified handle for usewith the suturing instrument of FIGS. 5A-5C;

FIG. 5H is a schematic plan view of a modified elongate body member foruse with the suturing instrument of FIGS. 5A-5C;

FIG. 6A is a schematic perspective view of one embodiment of a suturinginstrument having a deflectable and pivotable distal portion inaccordance with the invention;

FIG. 6B is an enlarged schematic perspective view of the deflectabledistal portion of the suturing instrument of FIG. 6A;

FIG. 6C is a schematic perspective view of the proximal portion of thesuturing instrument of FIG. 6A;

FIG. 6D is a schematic perspective view of the deflection and rotationmechanisms of the suturing instrument of FIG. 6A;

FIG. 6E is a schematic perspective view of an alternative embodiment ofa suturing instrument having a deflectable distal portion;

FIGS. 6F-6H are schematic perspective views of the deflectable distalportion of the suturing instrument of FIG. 6E in different positions;

FIG. 6I is a schematic cross-sectional view of the suturing instrumentof FIG. 6E;

FIG. 6J is a schematic cross-sectional view of one embodiment of alocking mechanism for use with a suturing instrument in accordance withthe invention;

FIG. 6K is a schematic cross-sectional view of an alternative embodimentof the locking mechanism of FIG. 6J;

FIG. 7A is a schematic perspective view of a suturing instrument havinga distal portion that is pivotable about one axis in accordance with theinvention;

FIGS. 7B and 7C are enlarged schematic perspective views of thepivotable distal portion of the suturing instrument of FIG. 7A;

FIG. 7D is a schematic perspective view of a suturing instrumentincluding a distal portion that is pivotable about two axes inaccordance with the invention;

FIGS. 7E-7H are enlarged schematic perspective views of the distalportion of the suturing instrument of FIG. 7D;

FIGS. 8A-8C are schematic plan views of a suturing instrument includingan alternative embodiment of a pivotable distal portion in accordancewith the invention;

FIG. 8D is an enlarged schematic view of the distal portion of thesuturing instrument of FIG. 8A;

FIG. 8E is an enlarged schematic cross-sectional view of the distalportion of the suturing instrument of FIG. 8C;

FIG. 9A is a schematic plan view of a suturing instrument including analternative embodiment of a pivotable distal portion of a suturinginstrument in accordance with the invention;

FIG. 9B is an enlarged schematic partial cross-sectional view of thedistal portion of the suturing instrument of FIG. 9A;

FIG. 9C is an enlarged schematic partial cross-sectional view of thedistal portion of the suturing instrument of FIG. 9A in a pivotedposition;

FIG. 10A is a schematic cross-sectional view of an alternativeembodiment of a pivotable distal portion of a suturing instrument inaccordance with the invention;

FIG. 10B is a schematic cross-sectional view of the pivotable distalportion of FIG. 10A in a pivoted position;

FIG. 11 A is a schematic cross-sectional view of an alternativeembodiment of a pivotable distal portion of a suturing instrumentincluding a drum-and-camshaft needle deployment mechanism in accordancewith the invention;

FIG. 11B is a schematic cross-sectional view of the distal portion ofthe suturing instrument of FIG. 11 A with a needle deployment mechanismin a deployed position;

FIG. 12A is a schematic perspective view of a suturing instrumentconfigured for use with an endoscope in accordance with the invention;

FIG. 12B is a schematic perspective view of a distal portion of thesuturing instrument of FIG. 12A attached to a sheath having a carrierdrive wire disposed therein; and

FIG. 12C is a schematic perspective view of a pivotable distal portionof the suturing instrument of FIG. 12A.

DESCRIPTION

Referring to FIG. 1A, in one embodiment, a suturing instrument 100includes a handle 102, an elongate body member 104, and a needledeployment mechanism 110 disposed within the elongate body member 104and the handle 102. The suturing instrument 100 also includes a distalportion 106 and a proximal portion 108. The elongate body member 104 ismechanically coupled to the handle 102 at the proximal portion 108 andthe suturing components are at least partially disposed within thedistal portion 106 of the suturing instrument 100.

The handle 102 can take a variety of forms, for example, the handle 102could be one of the types compatible with suturing systems availablefrom Boston Scientific Corporation of Natick, Mass. in particular withthe Capio® Push & Catch suturing system. A suture clip 144 may becoupled to the handle 102 or the elongate body member 104 and used tohold an end of one or more sutures 136 prior to placement in a patient.Generally, the needle deployment mechanism 110 extends longitudinallythrough the elongate body member 104 to the distal portion 106 of thesuturing instrument 100, where the needle deployment mechanism 110 iscoupled to a needle 128 (shown in FIG. 2A). The needle deploymentmechanism 110 moves the needle 128 between a retracted position and adeployed position. One possible needle deployment mechanism 110 is shownin greater detail in FIGS. 1B and 1C.

Referring to FIG. 1B, in one embodiment, the proximal portion 108 of thesuturing instrument 100 includes the handle 102, the elongate bodymember 104, the suture clip 144, and the needle deployment mechanism110. The needle deployment mechanism 110 includes an actuator button 117and a shaft 116 that together form an actuator 112. The needledeployment mechanism 110 also includes a bearing 118 and a button end119 that defines a hole 121 formed therein. The hole 121 is preferablyformed along the central longitudinal axis of the button end 119. Thebearing 118 rides along the surface of a lumen 105 that is defined bythe inside diameter of the elongate body member 104. A wireform 103 isinserted into the hole 121 of the button end 119, so that the wireform103 is coupled to the actuator button 117. A spring 115 encircles thewireform 103, abuts the button end 119, and is compressed between thebutton end 119 and a spring washer 113. The spring washer 113 is seatedupon a center tube 107. The center tube 107 is housed by the lumen 105and is constrained in the distal portion 106. A pusher wire 111 isattached to the wireform 103 by means of a weld, a coupling, adhesive,or other means, and is slidably disposed within a guidance sleeve 109,the sleeve 109 being disposed within the surface of a lumen 123 definedby the inside diameter of the center tube 107.

In one embodiment, the pusher wire 111 is constructed of an elasticmaterial having “superelastic” properties. Such a material may includealloys of In—Ti, Fe—Mn, Ni—Ti, Ag—Cd, Au—Cd, Au—Cu, Cu—Al—Ni, Cu—Au—Zn,Cu—Zn, Cu—Zn—Al, Cu—Zn—Sn, Cu—Zn—Xe, Fe₃Be, Fe₃Pt, Ni—Ti—V, Fe—Ni—Ti—Co,and Cu—Sn. In the illustrative embodiment, the superelastic material isa nickel and titanium alloy, commonly known as Nitinol®. available fromMemry Corp of Brookfield, Conn. or SMA Inc. of San Jose, Calif., sochosen for its combination of properties that allow for bendability andhigh column strength when constrained. The ratio of nickel and titaniumin Nitinol® may vary. One preferred example includes a ratio of about50% to about 56% nickel by weight. Nitinol® also possesses shaperetention properties.

Referring to FIG. 1C, the distal portion 106 of the elongate body member104 includes the distal components of the needle deployment mechanism110 (described in detail below), an operative portion 126, and a needlecatch 122. In one embodiment, the operative portion 126 has an arcuateshape and partially encircles a suturing field 176. The operativeportion 126 also defines a lumen 178 therein having a needle exit port120 at an opening into the suturing field 176. A needle 128 is disposedin the needle exit port 120 and is held in place by a slight frictionfit. In one embodiment, the suture 136 is attached to the needle 128.The free end of the suture 136 extends out of a suture slot 146.

Referring again to the needle deployment mechanism 110, the pusher wire111 is attached by welding or other means to a coupling 150, which isslidably disposed within a track 152. The coupling 150 is attached to acarrier wire 154, which, by virtue of its attachment to the coupling150, is also slidably disposed within the track 152. The coupling 150abuts a backstop washer 156 that is slidably disposed about the pusherwire 111 and is contained within a pocket 160 that includes a back wall162, against which the backstop washer 156 rests. The track 152terminates distally in a pocket 164 that includes a wall 166. A downstopwasher 158 is slidably disposed about the carrier wire 154 andconstrained within the pocket 164.

The carrier wire 154 is mechanically coupled to an extendable needlecarrier 124 by welding, coupling, use of adhesives, or by other means.The needle carrier 124 is slidably disposed in the lumen 178 of theoperative portion 126 and has a lumen 125 formed at a distal end of theneedle carrier 124. The lumen 125 is dimensioned to releasably receivethe non-penetrating end of the needle 128. The needle carrier 124 isconfigured to push the needle 128 out of the needle exit port 120through tissue proximate the suturing field 176, and into the needlecatch 122, as will be described in further detail below. In oneembodiment, the needle 128 is held within the lumen 125 by a slightfriction fit.

FIG. 2A depicts one embodiment of the needle 128 for use in a suturinginstrument in accordance with the invention. In this embodiment, theneedle 128 includes a penetrating tip 130 and a shaft 134 coupled to thetip 130, thereby forming a shoulder 132. The shaft 134 is coupled to thesuture 136. Other configurations of the needle 128 can also be usedwithout deviating from the scope of the invention. As shown in FIG. 1C,in one embodiment, when the needle 128 is disposed in the needle exitport 120, the free end of the suture 136 extends out of a needle carriersuture slot 148 and the suture slot 146.

Referring to FIG. 2B, the needle catch 122 includes openings 170 definedby successive ribs 172. When the needle catch 122 receives the needle128 coupled to the suture 136 through opening 170, the ribs 172 deflectslightly to allow the needle 128 to pass through. After the shoulder 132has passed the ribs 172, the ribs 172 spring back to their originalposition defining the openings 170, and the needle 128 remains capturedin the needle catch 122. The openings 170 are chosen to be smaller indimension than the shoulder 132. This causes the needle catch 122 toretain the needle 128, because the flat rear surface of the shoulder 132prevents the needle 128 from passing back through the opening 170. Whenit is necessary to remove the needle 128 from the needle catch 122, theneedle 128 may be moved toward an enlarged portion 174 of the opening170. The enlarged portion 174 is sized to allow the shoulder 132 to passthrough without resistance. The needle catch 122 may be constructed ofthin stainless steel of high temper, such as ANSI 301 full hard. Theneedle catch 122 may be fabricated by means of stamping, lasermachining, or chemical etching.

Referring again to FIGS. 1A-1C and 2A-2B, in operation, a user (such asa physician or other medical personnel) actuates the needle deploymentmechanism 110 by pushing on the button 117, which, via the attachment tothe wireform 103, is attached to the pusher wire 111, moves the coupling150 along the track 152 concomitantly moving the carrier wire 154, whichin turn slidably moves the needle carrier 124 through the lumen 178towards the needle exit port 120. The user continues to push the button117 until the needle carrier 124 receives the needle 128 in the lumen125, and further until the needle 128 penetrates tissue proximate thesuturing area 176 and then enters and is retained in the needle catch122. Then, the user releases the button 117 and the spring 115 urges thebutton 117 proximally, thereby moving the pusher wire 111, the coupling150, the carrier wire 154, and the needle carrier 124 proximally alongwith the button 117 to the retracted position. As the needle carrier 124moves back to the retracted position, the needle 128 slides out of thelumen 125 and the needle is released from the needle carrier 124.

In one embodiment, after one or more sutures 136 have been placed, theuser withdraws the suturing instrument 100 from the patient. The userthen detaches one or more sutures 136 from one or more needles 128 andties a knot or knots in the sutures 136. The user can then use a knotpusher 184 to push one or more knots into the patient as the knots aretightened.

The suturing instrument's component materials should be biocompatible.For example, the handle 102, the elongate body member 104, and portionsof the needle deployment mechanism 110 may be fabricated from extruded,molded, or machined plastic material(s), such as polypropylene,polyethylene, polycarbonate, or glass-filled polycarbonate. Othercomponents, for example the needle 128, may be made of stainless steel.Other suitable materials will be apparent to those skilled in the art.The material(s) used to form the suture should be biocompatible. Thesurgeon will select the length, diameter, and characteristics of thesuture to suit a particular application. Additionally, the mechanicalcomponents and operation are similar in nature to those disclosed inU.S. Pat. Nos. 5,364,408 and 6,048,351, and commonly owned U.S. patentapplication Ser. No. 10/210,984, each of which is incorporated byreference herein in its entirety.

FIGS. 3A and 3B depict two embodiments of a suturing instrument having amulti-load cartridge 140 in accordance with the invention. Such asuturing instrument advantageously allows the user to place multiplesutures without removing the suturing instrument from the surgical site.According to both embodiments, the suturing instrument 100 includes thecartridge 140 that houses two or more needles 128 disposed therein.Referring to FIG. 3A, the cartridge 140 is integrally formed within thedistal portion 106. In this embodiment, the distal portion 106 defines asidewall access opening 141 to allow the user to load one or moreneedles 128 into the cartridge 140. Referring to FIG. 3B, the cartridge140 is either integrally formed or removably disposed at a distal end142 of the operative portion 126. Having a removable cartridge allowsthe user to choose a cartridge having a specific number of needles for aspecific application. Also, the suturing instrument 100 may be reusablewith different needle cartridges.

Referring still to FIG. 3B, the multi-load needle cartridge 140 definesan exit aperture 145 and a needle loading slot 147. The multi-loadneedle cartridge 140 is designed to hold essentially any number ofneedles, for example, 2-20 needles. The multi-load needle cartridge 140is preloaded and capable of feeding the needle and suture assembly intothe needle carrier 124. In one embodiment, the cartridge 140 can bereloaded by the user in situ by adding needles 128 using, for example,the sidewall access opening 141 (FIG. 3A) or the exit port 120 (FIG.3B). The multi-load needle cartridge 140 may include a push plate 196and a spring 198 that biases the push plate 196 towards the exitaperture 145.

Both embodiments operate in essentially the same manner, enabling a userto place multiple sutures 136 in a patient without removing the suturinginstrument 100 from the surgical site. As described above, the preloadedmulti-load needle cartridge 140 can include one or more needles 128 eachwith the suture 136 coupled thereto. Referring to FIG. 3B, in oneembodiment, the needle cartridge 140 includes three needles 128 a, 128b, 128 c. Sutures 136 a, 136 b, 136 c extend out of the suture slot 146.Alternatively, the sutures 136 may run through the elongate body member104. The first needle 128 a is disposed in the exit aperture 145, andthe remaining needles 128 b, 128 c are disposed in the loading slot 147.

The needle carrier 124, which is part of the needle deployment mechanism110, is sequentially connectable to the needles 128 stored in thecartridge 140. This means that each needle 128 stored in the needlecartridge 140 is connected to, and then deployed by, the needle carrier124 one at a time in the order the needles 128 are dispensed from theneedle cartridge 140.

In operation, the user inserts the elongate body member 104 into apatient and orients the elongate body member 104 so that the tissue tobe sutured is disposed proximate the suturing field 176 and the needleexit port 120 is proximate to or in contact with the tissue. The userthen pushes the button 117 (FIG. 1B), as described above. Pushing thebutton 117 causes the needle carrier 124 to receive the needle 128 a inthe lumen 125 and then to extend out of the needle exit port 120 andpush the needle 128 a through the tissue. As the first needle 128 a ispushed through the tissue, the first needle 128 a pulls the first suture136 a through the tissue. As the user continues to push the button 117,the needle carrier 124 continues to advance out of the needle exit port120 and directs the first needle 128 a and the first suture 136 a towardthe needle catch 122. The user continues to push the button 117 untilthe first needle 128 a contacts and becomes captured by the needle catch122. The user then retracts the needle carrier 124 by releasing thebutton 117, as previously described.

After the user retracts the needle carrier 124, the first needle 128 aand the first suture 136 a are left captured within the needle catch122, with the first suture 136 a extending through the tissue. When theneedle carrier 124 returns to a fully retracted position, the spring 198causes the needle push plate 196 to push the second needle 128 b intothe exit aperture 145. The needle 128 b is thereby forced through theloading slot 147 and either into the lumen 125 of the needle carrier 124or in position to be captured by the needle carrier 124. The secondsuture 136 b extends out of the suture slot 146. The user then advancesthe needle carrier 124 as described above until the second needle 128 bis captured by the needle catch 122. The user then retracts the needlecarrier 124 as described above leaving the second needle 128 b and thesecond suture 136 b captured by the needle catch 122. This procedure canbe repeated for the third needle 128 c, or for as many needles as may bestored in the needle cartridge 140. After one or more sutures 136 havebeen placed, the user withdraws the suturing instrument 100 from thepatient. The user detaches the suture(s) 136 from the needle(s) 128 andties a knot or knots in the suture(s) 136. The user can then use theknot pusher 184 to push the knot(s) in the patient as the knot(s) istightened.

Alternatively, other mechanisms could be used to advance the needle 128from the needle cartridge 140 to the carrier 124. In one embodiment, theneedles 128 in the needle cartridge 140 are held in the loading slot 147by a friction fit and are pushed into the exit aperture 145 when theneedle push plate 196 is activated by the user. For example, instead ofthe spring 198, a dispensing control rod coupled to a button on thehandle 102 and the push plate 196 may be provided. Alternatively, aspring release mechanism coupled to the spring 198 and a button on thehandle 102 may be provided to enable the user to release the spring 198so that the push plate loads the needle 128 into the exit aperture 145to be received in the lumen 125 of the needle carrier 124. In anotherembodiment, the user may load the needle 128 into the exit aperture 145by pulling the free end of the suture 136. In yet another embodiment,the suturing instrument 100 may include a means for pulling the free endof the suture 136 such as, for example, a spool or a lever attached tothe elongate body member and disposed, for example, on or within thehandle 102

Referring to FIG. 4A, in another embodiment, the operative portion 126of the distal portion 106 of the suturing instrument 100 includes amechanism for deploying two or more needles 128. The needles 128 can bedeployed sequentially or simultaneously. The deployment mechanismincludes a separate needle carrier 124 a, 124 b for each needle 128. Thehandle 102 can include one button 117 to advance both needles 128 or thehandle 102 can include two buttons 117 a, 117 b to advance the needles128 sequentially or simultaneously (if pressed at the same time).Passing two single armed needles into an incision site enables a user toplace, for example, two ligating sutures simultaneously, withdrawing thedevice, and tying two knots. Ligating between the sutures is possible ina shorter time-frame.

In operation, this embodiment functions largely the same way as theembodiments previously described. For simultaneous advancement, the useradvances the needle carriers 124 by pressing the button(s) 117 (FIG. 1A)until the needles 128 are driven through the tissue and captured by theneedle catch 122. After the needles 128 are captured in the needle catch122, the needle carriers 124 are retracted. For sequential advancement,the user advances one needle carrier 124 a by pressing one button 117 auntil the first needle 128 a is driven through the tissue and capturedby the needle catch 122. The user then retracts the first needle carrier124 a. The user then advances the second needle carrier 124 b bypressing the second button 117 b until the second needle 128 b is driventhrough the tissue and captured by the needle catch 122. The user thenretracts the second needle carrier 124 b.

Referring to FIGS. 4B-4D, in another embodiment, the distal portion 106includes two separate operative portions 126 a, 126 b separated a wedge200. The operative portions 126 a, 126 b include the needle exit ports120 a, 120 b that are deflectable or spreadable outward relative to theelongate member 104 to adjust the distance between the exit ports 120 a,120 b. The user may control the amount of separation between theoperative portions 126 a, 126 b and, therefore, the distance between theexit ports 120 a, 120 b with a control lever 202 in the handle 102.Other mechanisms that can be used to deflect the operative portions 126a, 126 b include, but are not limited to, a cam or link, an elbowlinkage, a rotational separation along a longitudinal axis 350 of thedevice, a pre-made track and follower assembly, or a manual separator.In a particular embodiment, the user actuates the control lever 202,thereby advancing the wedge 200 and widening the space between the twooperative portions 126 a, 126 b.

One benefit of the embodiments depicted in FIGS. 4A-4D and describedabove is that spreading the operative portions 126 a, 126 b allows auser to create a controlled or predetermined distance between the needlecarriers' tissue entrance points. This feature enables the placing ofsutures 136 at different spacing sequences. In addition, theseembodiments also provide a means to place a double-armed suture (asuture with a needle at each end) in a patient. Referring to FIGS. 4Eand 4F, the needle deployment mechanism 110 generally functions the sameway as previously described and can be used to place a single suture 136coupled to two needles 128 a, 128 b through tissue 204 (FIG. 4E) or toplace two sutures 136 a, 136 b coupled to two needles 128 a, 128 b,respectively (FIG. 4F) through tissue 204. Referring to FIG. 4E, where asingle suture 136 is attached to the two needles 128 a, 128 b, thesuture 136 is placed perpendicularly to the longitudinal axis 350 of thesuturing instrument. Referring to FIG. 4F, where separate sutures 136 a,136 b are attached to each of the two needles 128 a, 128 b, the sutures136 a, 136 b can be placed in essentially any orientation relative tothe longitudinal axis 350 of the suturing instrument.

Referring to FIGS. 5A-5H, in yet another embodiment, the suturinginstrument 100 is modified to allow the user to place a so-called “whipstitch,” i.e., a continuous running suture. Typically, the suturinginstrument must be removed from the surgical site so the user maydisengage the needle from the needle catch and either reload theexisting needle into the needle carrier or load a new needle and sutureinto the instrument. In this embodiment, the user can remove the needlefrom the catch and reload the needle into the needle carrier withoutremoving the suturing instrument 100. This allows the user to place arunning stitch. This embodiment may be combined with any number of theother embodiments described herein.

Generally, the instrument is used to secure tissue with a continuousrunning suture by passing the suture through tissue, catching the sutureneedle, ejecting the needle from the catch in situ, and reloading theneedle into the carrier. The suturing instrument 100 essentiallyoperates in the same manner as the other instruments described herein.The instrument is modified, however, to add a needle reloading mechanism205 described in detail below that, when advanced, pushes the needle 128along the needle catch 122 to an opening that permits the needle to bedischarged from the catch 122. The needle 128 can be discharged by, forexample, pulling on the suture 136. Continued pulling on the suture 136can reposition the needle 128 into the end of the needle carrier 124.The reloaded carrier 124 can then be advanced again, continuing sutureplacement through multiple tissue passes, resulting in a whip stitch.

FIG. 5A depicts the distal portion 106 of the suturing instrument 100.The needle carrier 124 and needle catch 122 are disposed in the distalportion 106. The needle catch 122 is similar to the catch describedhereinabove with respect to FIG. 2B; however, the catch 122 is slightlymodified to include two protrusions 210 disposed between the ribs of thecenter opening 213 to create a narrow portion in the opening 213. Theprotrusions 210 prevent the needle 128 from moving to the largeropening, i.e., the needle reloading aperture 174, in the catch 122before the suturing instrument 100 is ready for reloading. In oneembodiment, the needle catch 122 is slidably movable towards the needleexit port 120.

FIG. 5B depicts a needle reloading mechanism 205. The mechanism 205includes a pusher rod 208 and an actuator 206. The actuator 206 isgenerally perpendicularly disposed relative to the rod 208 and isattached to the rod 208 by, for example, welding or other attachmentmeans. Additionally, the mechanism 205 includes a hook 211 that couplesto a spring 207 located within the handle 102 (FIG. 5C). The spring 207acts to return the mechanism 205 to its original position once theactuator 206 is released. In a particular embodiment, the mechanism 205is slidably disposed within the suturing instrument 100.

Referring to FIG. 5C, the proximal portion 101 of the suturinginstrument 100 is modified compared to the embodiment shown in FIG. 1A.Specifically, the handle 102 is modified to house at least a portion ofthe mechanism 205, as well as to include a slot 209 to house theactuator 206.

FIGS. 5D-5F are enlarged partial views of the needle catch 122 andpusher rod 208. As shown, the needle 128 is held within the centeropening 213 of the catch 122 between two ribs or flexible edges 172. Thepusher rod 208 includes a concave distal end that at least partiallysurrounds the needle 128 when the rod 208 is advanced into contact withthe needle 128 (FIG. 5E). The pusher rod 208 pushes the needle 128 alongthe center opening 213 to the larger opening 174. The needle 128 ismoved past the protrusions 210 by the force of the pusher rod 208. Theforce causes the ribs 172 to spread slightly to allow the needle 128 topass. When the pusher rod 208 is fully advanced, the needle 128 will bepositioned within the reloading aperture 174 (FIG. 5F). Alternatively,the needle 128 could be held within one of the lateral openings 215, 217in a catch 122 further modified to include protrusions 210 in thelateral openings 215, 217. The pusher mechanism 205 can also be modifiedto push a needle 128 held in one or both of the lateral openings 215,217.

FIG. 5G depicts the modified handle 102. As described hereinabove, thehandle 102 includes the slot 209 for the actuator 206 and a void 217 forhousing the proximal portion of the rod 208 and the spring 207 and hook211. While the actuator 206 described herein is slidably disposed withinthe handle 102, other mechanical linkages are contemplated, for example,a push button and push wire assembly. The dimensions shown are forillustrative purposes only and are not meant to be limiting.

FIG. 5H depicts the modified elongate body member 104 compared to theembodiment depicted in FIG. 1A. The body member 104 is modified to houseat least partially the pusher mechanism 205, specifically the pusher rod208. The body member 104 includes a slot 219 that runs substantially theentire length of the body member 104. The pusher rod 208 is slidablydisposed within the slot 219.

Operation of the instrument is described generally with reference toFIGS. 5A-5H. The basic operation is similar to that describedhereinabove with reference to FIGS. 1A-1C, insofar as the user pressesthe button 117 thereby advancing the needle carrier 124 and pushing theneedle 128 into the catch 122. After the user drives the needle throughthe tissue 204 and into the catch 122, the user positions the distalportion 106 of the suturing instrument 100 so that the tissue 204 is nolonger in the surgical field 176. During operation, the suture 136 ispreferably maintained in tension. A free end of the suture 136 remainsoutside of the surgical site and accessible to the user. Next, the useradvances the needle reloading mechanism 205 into contact with the needle128 by pushing the actuator 206 distally. Once the pusher mechanism 205is fully advanced, the needle 128 is positioned within the needlereloading aperture 174. In this position, the free end of the suture 136can be pulled to release the needle 128 from the catch 122 and, in turn,lead the needle 128 into the needle carrier. In addition, the needlecarrier can be partially advanced to assist reloading of the needle 128into the carrier. Also, the distal end of the needle carrier 124 can bemodified to facilitate reloading. For example, the distal end of thecarrier 124 and the lumen 125 could be enlarged to create a sufficientlead in for recapturing the needle 128. Further, as described above, theneedle catch 122 may be slidable distally to position the needle 128close to the carrier 124 before releasing the needle 128. After theneedle 128 is recaptured in the lumen 125 of the needle carrier 124 andthe needle carrier 124 is fully retracted into the operative portion126, the user maneuvers the suturing instrument 100 and/or the tissue204 so that the tissue 204 is disposed again proximate the suturingfield 176 and the exit port 120 is proximate to the next stitchingposition in the tissue 204.

Referring to FIGS. 6A and 6B, in another embodiment, the suturinginstrument 100 includes a distal portion 106 that is independentlydeflectable and/or pivotable relative to the elongate member 104.Specifically, the distal portion 106 includes a deflectable portion 300that connects the elongate body member 104 to the distal portion 106.The distal portion 106 is deflectable relative to the elongate member104 in the “A-P” and “I-S” directions. Also, the operative portion 126of the distal portion 106 may be pivotable about pivot nodes that definean axis 330 perpendicular to the longitudinal axis 350 of the elongatemember 104. Alternatively, the operative portion 126 of the distalportion 106 may be pivotable about a pin 402 that is perpendicular tothe longitudinal axis 350 of the elongate member 104 and defines theaxis 330.

Referring to FIGS. 6C and 6D, movements of the distal portion 106 arecontrolled by one or more deflection control members 302, 306, and/or apivot control lever 304 included in the proximal portion 108, forexample, in the handle 102. The deflection control members 302 arecoupled to a tension roller 315. The deflection control members 306 arecoupled to a tension roller 311. Tension members 335 are connected tothe tension rollers 311, 315, extend through the elongate member 104,and are coupled to a front portion 301 a of a deflectable portion 300for causing the distal portion 106 to deflect. The pivot control lever304 is coupled to a pivot wire 334 that extends along the longitudinalaxis 350 of the elongate member 104 and is coupled to the operativeportion 126 of the distal portion 106 to cause it to pivot. The tensionmembers 335 and the pivot wire 334 pass through a wire equalizer 313disposed within the elongate body member 104 and are formed from, forexample, stainless steel or Nitinol® alloy

In operation, the user can pivot the operative portion 126 of the distalportion 106 about the axis 330 perpendicular to the longitudinal axis350 of the elongate body member 104 by manipulating the pivot controllever 304 in the handle 102. The pivot control lever 304, when turned,causes the pivot wire 334 to pull or push the operative portion 126,thereby rotating it around the axis 330.

The deflection control members 302, 306 cause the tension rollers 311,315 to turn when the deflection control members 302, 306 are turned,thereby causing the distal portion 106 to bend. Specifically, the usercan bend the deflectable portion 300 of the distal portion 106 at itsrear portion 301 b up to +/−90 degrees (A-P direction) by manipulatingthe deflection control member 302, that causes the tension roller 315 torotate and either tighten the tension member 335 a and relax the tensionmember 335 p, or tighten the tension member 335 p and relax the tensionmember 335 a. The user can also bend the deflectable portion 300 at itsrear portion 301 b up to +/−90 degrees (I-S direction) by manipulatingthe deflection control member 306, that causes the tension roller 311 torotate and either tighten the tension member 335 i and relax the tensionmember 335 s, or tighten the tension member 335 s and relax the tensionmember 335 i.

Referring to FIGS. 6E-6H, in another embodiment, the suturing instrument100 includes a distal portion 106 having a beveled surface 307 a forcontacting the elongate body member 104 and the elongate body memberincludes a beveled surface 307 b for contacting the distal portion.According to one feature of this embodiment, the acute angle defined bythe beveled surface 307 a and the acute angle defined the beveledsurface 307 b are substantially equal. In one embodiment, each of theseangles substantially equals 45 degrees. The surfaces 307 a, 307 b aresecured against each other by a spring 310 disposed in the elongatemember 104. In an aligned position, the surfaces 307 a, 307 b arealigned such that the distal portion 106 and the elongate body member104 combine to produce a shaft that is substantially linear. The handle102 includes a deflection control lever or member 312 that is coupled toa first end of a rod 320 that extends through the elongate member 104. Asecond end of the rod 320 is coupled to the distal portion 106. When theuser manipulates the deflection control lever 312, the distal portion106 rotates and, by virtue of the contacting beveled surfaces 307 a, 307b, a rotation point 308 forms, thereby enabling suturing of tissue atany angle relative to the elongate body member's longitudinal axis 350(or angles of surface contact).

In the embodiment shown in FIG. 6J, the suturing device 100 includes alocking mechanism that includes a ball 314 and a plurality of detents316. The ball 314 is coupled to the beveled surface 307 b of theelongate member 104 at a point radially outward from the longitudinalaxis 350 of the distal portion 106. The ball 314 is positioned on theelongate member 104 to allow it to contact the beveled surface 307 a ofthe distal portion 106. Each of the plurality of detents 316 may bedisposed equally about the circumference about the beveled surface 307 aof the distal portion 106. The circle of detents 314 may be centered onthe longitudinal axis of the distal portion 106. Each detent 316 mayhave a radial distance from the longitudinal axis of the distal portion106 equal to that of the ball 314. As the user deflects the distalportion 106 by manipulating the deflection control lever 312, the ball314 moves out of one detent 316 and into another detent 316. The detentsare spaced such that the distal portion rotates in a stepwise manner.Each step may be a fixed number of degrees of rotation. In anotherembodiment, the ball 314 is coupled to a spring 318 disposed in anaperture 321 formed in the beveled surface 307 b. The spring 318provides enough force to keep the ball 314 socketed in one of thedetents when the user is not trying to change the angle of the distalportion 106 relative to the longitudinal axis 350 of the elongate bodymember 104. The spring 318 is, however, compressible such that the ball314 is at least partially withdrawn into the aperture 321 and the usercan easily change the angle of the distal portion 106 relative to thelongitudinal axis 350 of the elongate body member 104 by moving the ball314 from one detent 316 a to another detent 316 b.

In another embodiment, shown in FIG. 6K, the distal portion 106 and theelongate member 104 may include meshed teeth 319 a, 319 b that engage tolock the distal portion 106 and the elongate member 104 at a particularangle. In operation, the user pushes the distal portion 106 distallyfrom the elongate member 104, so the beveled surfaces 307 a, 307 b donot contact each other and the teeth 319 a, 319 b no longer engage, andthen deflects the distal portion 106 to a desired angle. Then, when thebeveled surfaces 307 a, 307 b are brought into contact with each other,the teeth 319 a, 319 b engage or mesh to lock the distal portion 106 inplace.

Referring to FIGS. 7A-7C, in another embodiment, the suturing instrument100 includes a distal portion 106 that is independently pivotable aboutthe axis 330 perpendicular to the longitudinal axis 350 of the elongatemember 104 and rotatable about the longitudinal axis 350 of the elongatemember 104. In one version of this embodiment, the degree of pivot iscontrolled by a pivot control lever 400 located on the handle 102 andcoupled to a pivot control mechanism disposed within the elongate member104. The pivot control mechanism is coupled to the distal portion 106.When the user manipulates the pivot control lever 400 slidably movingthe pivot control mechanism within the elongate member 104, the distalportion 106 pivots about the pivot axis 330. This embodiment enables thesuturing of tissue at angles up to 90 degrees from the longitudinal axis350 of the elongate body member 104. The suturing instrument 100 alsoallows for removal from a 10 mm trocar without repositioning the distalportion 106.

Referring to FIGS. 7D-7H, in an alternative embodiment, the suturinginstrument 100 includes a pivoting and rotating distal portion 106. Thesuturing instrument 100 also includes a pivot control lever 504, arotation control lever 506, and a needle deployment trigger 502. Theuser can pivot the distal portion 106 by manipulating the pivot controllever 504 on the handle 102. The distal end 106 can be pivoted to aposition perpendicular to the tissue plane to be sutured. The internaloperation of the pivoting mechanism is similar to embodiments discussedabove. The user can also rotate the distal portion 106 by manipulatingthe rotation control lever 506 also disposed on the handle 102, that iscoupled to a rotation mechanism, which, in turn, is coupled to thedistal portion 106. The needle 128 is deployed by pulling the needledeployment trigger 502. The needle deployment mechanism operates similarto other embodiments previously described.

Referring to FIGS. 8A-8E, in another embodiment, the suturing instrument100 includes a pivoting distal portion 106 and a pivot control lever508. The elongate member 104 includes an outer portion 516 and an innerportion 518, and is coupled to the distal portion 106 at a pivot point514 and via linkage 512 (FIG. 8D). The user controls the pivoting actionby manipulating the pivot control lever 508, thereby causing the outerportion 516 to slide relative to the inner portion 518. Pushing thecontrol lever 508 causes the outer portion 516 to push the linkage 512,which, in turn, pushes the distal portion 106. As the distal portion 106is pushed by the linkage 512, the distal portion pivots about the pivotpoint 514. The distal portion 106 can pivot up to 90 degrees relative tothe longitudinal axis 350 of the elongate body member 104. Pulling thecontrol lever 508 causes the outer portion 516 to pull the linkage 512,which pulls the distal portion 106. As the distal portion 106 is pulledby the linkage 512, the distal portion 106 pivots about the pivot point514 and returns to its original position. In one embodiment, the controllever 508 maybe be coupled to the outer portion 516 via a pin 509 orother attachment means. Alternatively, the control lever 508 is notcoupled to the outer portion 516, but is pushed into contact with theouter portion 516 via, for example, the pin 509. Further, the outerportion 516 may be biased against the control lever 508 by a spring thatcauses the distal portion 106 to return to its starting position whenthe control lever 508 is released.

According to this embodiment of the invention, in one version, theneedle deployment mechanism 110 includes a loop 510 for advancing theneedle carrier 124. The loop 510 is formed from a resilient material,such as rubber. The loop 510 is coupled to the button 117 at theproximal end of the elongate member 104 and coupled to the needlecarrier 124 at a distal end. In operation, the user presses the button117, which causes the loop 510 to advance. As the loop 510 advances, theneedle carrier 124, which is coupled to the loop 510, also advancesuntil the needle 128 in the needle carrier 124 is captured by the needlecatch 122. After the needle 128 is captured in the needle catch 122, theuser releases the button 117 and the loop 510 retracts thereby causingthe needle carrier 124 to also retract.

Referring to FIGS. 9A-9C, in another version of this embodiment, theneedle deployment mechanism 110 in the distal portion 106 includes afirst gear 520, a second gear 524, and a linkage 522. The linkage 522 iscoupled to the first gear 520 and the needle carrier 124. In operation,the user manipulates the button 117, which causes the second gear 524 toturn. The second gear 524 engages the first gear 520, thereby causingthe first gear 520 to turn and pivot the distal portion 106. As thefirst gear 520 turns, the linkage 522 moves and advances the needlecarrier 124 until the needle 128 is captured by the needle catch 122.After the needle 128 is captured by the needle catch 122, the userreleases the button 117 and the first gear 524 and the second gear 520turn in the opposite direction causing the linkage 522 to retract theneedle carrier 124.

Referring to FIGS. 10A and 10B, in yet another embodiment, the needledeployment mechanism in the distal portion 106 includes a superelasticpusher 602. A proximal end of the superelastic pusher 602 is coupled tothe button 117 (shown in FIG. 1B) and a distal end of the superelasticpusher 602 is coupled to the needle carrier 124. In operation, the userpushes the button 117, which causes the superelastic pusher 602 toadvance the needle carrier 124 until the needle 128 is captured in theneedle catch 122. After the needle 128 is captured by the needle catch122, the user releases the button 117 and the superelastic pusher 602retracts the needle carrier 124. This embodiment operates similarly tothe embodiment described with reference to FIGS. 1A-1C. The superelasticpusher can be formed from an elastic material having “superelastic”properties, such as Nitinol®.

Referring to FIGS. 1A and 1B, in another embodiment, the needledeployment mechanism in the distal portion 106 includes a drum 608 and acamshaft 604. The drum 608 is coupled to a distal end of a push wire. Aproximal end of the push wire is coupled to the button 117. The drum 608is also coupled to the camshaft 604 and the camshaft 604 is coupled tothe needle carrier 124. In operation, the user pushes the button 117,which causes the push wire to rotate the drum 608. As the drum 608rotates, the camshaft 604 moves and advances the needle carrier 124until the needle 128 is captured in the needle catch 122. After theneedle 128 is captured by the needle catch 122, the user releases thebutton 117 and the push wire rotates the drum 608 in the oppositedirection, thereby causing the camshaft 604 to retract the needlecarrier 124. The push wire can be formed from, for example, stainlesssteel or nickel-titanium alloy.

Referring to FIGS. 12A-12C, in still another embodiment, the suturinginstrument 100 is configured to be used with an endoscope 708. Aproximal portion 712 of the suturing instrument 100 includes the handle102, a carrier drive wire socket 702 attached to a distal end 752 of thehandle 102, and an actuator 112 including a needle deployment button117. The proximal portion 712 also includes a scope adapter 706 having adistal end 718 that is connectable to an access port 724 of theendoscope 708 and a proximal end 720 that is connectable to the carrierdrive wire socket 702.

The suturing instrument further includes an elongate member 714 thatincludes a carrier drive wire 710, which can be formed from, forexample, stainless steel or a nickel-titanium alloy, covered by aflexible sheath 704. The sheath 704 is coupled to a distal portion 716.The carrier drive wire 710 is connectable to the needle carrier formoving a needle from the distal portion in accordance with any of theembodiments disclosed herein. Also, the distal portion 716 can bestationary, pivoting, or rotatable in accordance with any of theembodiments disclosed herein

In operation, the elongate member 714 is fed into a distal end 722,through a working channel 726, and out of an access port 724 of theendoscope 708. The distal end 718 of the adapter 706 is coupled to theaccess port 724 of the endoscope 708 and the carrier drive wire 710 isfed through the adapter 706. The carrier drive wire 710 is then coupledthe carrier drive wire socket 702 and the proximal portion 712 of thesuturing instrument 100 is secured to the proximal end 720 of theadapter 706. The endoscope 708 can then be inserted into a patient. Theadapter 706 can include any standard or custom fittings necessary tocouple to the access port 724 and the proximal portion 712 of thesuturing instrument 100. For example, the adapter 706 can include a luerfitting or a treaded fitting to couple to the endoscope 708.

In one embodiment, the sheath 704 is fixedly coupled to the distalportion 716, and the distal portion 716 can be rotated by rotating theflexible sheath 704, using, for example, a rotation controller 760disposed in the scope adapter 706. In another embodiment, the handle 102of the suturing instrument 100 includes two subassemblies. Thesubassemblies include a thumb-button/finger grasper assembly and athumb-button/scope assembly.

Other embodiments incorporating the concepts disclosed herein may beused without departing from the spirit and scope of the invention. Thedescribed embodiments are to be considered in all respects as onlyillustrative and not restrictive. Therefore, it is intended that thescope of the invention be only limited by the following claims.

What is claimed is:
 1. A suturing instrument, comprising: an elongatebody having a centerline longitudinal axis and comprising a distal endportion defining a distal terminal end, the distal end portion having ahorizontal axis perpendicular to the centerline longitudinal axis of theelongate body, the distal end portion having a first surface extendingto the distal terminal end and a second surface extending to the distalterminal end, the second surface being opposite to the first surface,the distal end portion defining a first operative portion and a secondoperative portion adjacent to the first operative portion such that aportion of the distal end portion is split into the first operativeportion and the second operative portion, the first operative portiondefining a first needle exit port and a first needle catch on the firstsurface, the second operative portion defining a second needle exit portand a second needle catch on the first surface, the first needle exitport and the first needle catch of the first operative portion and thesecond needle exit port and the second needle catch of the secondoperative portion configured to separately spread outwardly relative tothe longitudinal axis to adjust a separation distance between the firstneedle catch of the first operative portion and the second needle catchof the second operative portion along the horizontal axis; and a needledeployment mechanism for deploying a first needle carrier out of thefirst needle exit port of the first operative portion and deploying asecond needle carrier out of the second needle exit port of the secondoperative portion.
 2. The suturing instrument of claim 1 wherein a pathof the first needle carrier out of the first needle exit port and intothe first needle catch and a path of the second needle carrier out ofthe second needle exit port and into second needle catch aresubstantially parallel.
 3. The suturing instrument of claim 1 whereinthe needle deployment mechanism comprises an actuator coupled to thefirst needle carrier and the second needle carrier for simultaneouslydeploying the first needle earlier out of the first needle exit port andinto the first needle catch and the second needle carrier out of thesecond needle exit port and into the second needle catch.
 4. Thesuturing instrument of claim 1 wherein the needle deployment mechanismcomprises a first actuator coupled to the first needle carrier forcontrolling deployment of the first needle carrier and a second actuatorcoupled to the second needle carrier for controlling the deployment ofthe second needle earlier.
 5. The suturing instrument of claim 4 whereinthe first actuator and the second actuators are actuatable tosequentially or simultaneously deploy the first needle carrier and thesecond needle carrier.
 6. The suturing instrument of claim 1 wherein thefirst needle carrier has a distal end defining a lumen for receiving afirst needle therein and the second needle carrier has a distal enddefining a lumen for receiving a second needle therein.
 7. The suturinginstrument of claim 6 further comprising a first suture attached to thefirst needle and a second suture attached to the second needle.
 8. Thesuturing instrument of claim 6 further comprising a suture having afirst end attached to the first needle and a second end attached to thesecond needle.
 9. The suturing instrument of claim 1 further comprising:a separation actuator configured to control the separation distancebetween the first needle catch and the second needle catch.
 10. Thesuturing instrument of claim 9 wherein the separation actuator is acontrol lever, the control lever being operably coupled to a wedge, thecontrol lever configured to advance at least a portion of the wedge outof the elongate body and between the first operative portion and thesecond operative portion, thereby spreading apart the first needle catchand the second needle catch from each other along the horizontal axis.11. The suturing instrument of claim 10 wherein the elongate bodyincludes a proximal end portion, the proximal end portion defining ahandle portion, the control lever being coupled to the handle portion.12. The suturing instrument of claim 1 wherein the first needle catch isconfigured to retain a first needle releasably retained by the firstneedle carrier and the second needle catch is configured to retain asecond needle releasably retained by the second needle carrier.
 13. Thesuturing instrument of claim 1, wherein the first needle catch comprisesa plurality of openings and the second needle catch comprises aplurality of openings.
 14. The suturing instrument of claim 13, whereinthe plurality of openings in the first and second needle catches eachdefine a retention slot including at least two flexible edges.
 15. Thesuturing instrument of claim 1 wherein the elongate body is flexible.16. The suturing instrument of claim 1 wherein the distal end portion isrotatable about the longitudinal axis of the elongate body.
 17. Asuturing instrument, comprising: an elongate body including a distal endportion defining a distal terminal end, the distal end portion having afirst surface extending to the distal terminal end and a second surfaceextending to the distal terminal end, the second surface being oppositeto the first surface, the distal end portion defining a first operativeportion and a second operative portion adjacent to the first operativeportion such that a portion of the distal end portion is split into thefirst operative portion and the second operative portion, the firstoperative portion defining a first needle exit port and a first needlecatch on the first surface, the second operative portion defining asecond needle exit port and a second needle catch on the first surface;and a separation actuator configured to control a separation distancebetween the first needle catch and the second needle catch of the secondoperative portion, the separation actuator being configured to drive aseparator component between the first operative portion and the secondoperative portion thereby increasing the separation distance between thefirst needle catch and the second needle catch.
 18. The suturinginstrument of claim 17, wherein the separator component includes awedge.
 19. The suturing instrument of claim 17, wherein the separationactuator includes a control level.
 20. The suturing instrument of claim17 further comprising: a needle deployment mechanism for deploying afirst needle carrier out of the first needle exit port of the firstoperative portion and deploying a second needle carrier out of thesecond needle exit port of the second operative portion.